Vaccination of Pregnancy and Lactating Patients Against COVID-19
Evidence suggests that pregnant women are potentially at increased risk of severe COVID-19 associated illness and death compared to non-pregnant women:
- Increased risk of severe illness (ICU admission, mechanical ventilation and death)
- Might be an increased risk of adverse pregnancy outcomes, such as preterm birth and stillbirth.
mRNA vaccines are not live virus vaccines. These vaccines do not enter the nucleus and do not alter human DNA in the vaccine recipients. As a result, mRNA vaccines cannot cause any genetic changes.
- In addition, they are degraded quickly by normal cellular processes and don’t enter the nucleus of the cell.
mRNA SARS-CoV-2 vaccines currently available under FDA Emergency Use Authorization have not been tested in pregnant women. Therefore, there are no safety data specific to use in pregnancy or lactation.
- Studies in humans are ongoing and more planned
There are no current data on the safety and efficacy of mRNA COVID-19 vaccines administered simultaneously with other vaccines, including those commonly administered during pregnancy.
- CDC/ACIP recommends a minimum interval of 14 days before or after administration with any other vaccine.
While the vaccine has been shown to be extremely effective at preventing COVID-19 disease, its effect on viral transmission is yet to be determined. For this reason, it is important we continue using all tools available to us to protect ourselves and others. Vaccination is NOT a substitution for social distancing, mask use, and frequent hand hygiene.
Individuals who are pregnant/become pregnant after vaccination should be monitoring for pregnancy outcome information.
- There will be mandatory reporting of adverse pregnancy outcomes (major congenital anomalies, stillbirth, miscarriage) to Vaccine Adverse Event Reporting System (VAERS)
Summary of ACOG/SMFM/CDC Recommendations
Pregnancy
Vaccination should not be withheld from pregnancy individuals who meet criteria for vaccination based on ACIP recommended priority groups
There is no data to indicate that the vaccines should be contraindicated in pregnant individuals.
Pregnant individuals should be free to make their own decision in conjunction with their clinical team.
Considerations for vaccination:
- Level of COVID-19 community transmission, (risk of acquisition)
- Her personal risk of contracting COVID-19, (by occupation or other activities)
- The risks of other individuals in your household (immunocompromised, elderly, etc.).
- The risks of COVID-19 to her and potential risks to the fetus
- The efficacy of the vaccine
- The known side effects of the vaccine
- The lack of data about the vaccine during pregnancy
Pregnant women who experience fever following vaccination should be counseled to take acetaminophen as fever has been associated with adverse pregnancy outcomes.
Breastfeeding/Lactating Women
There are no data on the safety of COVID-19 vaccines in lactating women or the effects of mRNA vaccines on the breastfed infant or milk production/excretion.
mRNA vaccines are not considered live virus vaccines and are not thought to be a risk to the breastfeeding infant.
If a lactating woman is part of a group (e.g., healthcare personnel) who is recommended to receive a COVID-19 vaccine, she may choose to be vaccinated.
COVID-19 vaccine should be offered to lactating individuals similar to non-lactating individuals when they meet criteria for the receipt of the vaccine based on prioritization groups.
There is no need to avoid initiation or discontinue breastfeeding in patient who receive COVID-19 vaccine.
Individuals Contemplating Pregnancy
Vaccination is strongly encouraged for non-pregnant individuals within the ACIP prioritization groups.
If an individual receives a COVID-19 vaccine (1st or 2nd dose) and becomes pregnant within 30 days of receipt of the vaccine, participation in CDC’s V-SAFE program should be encouraged.
Routine testing for pregnancy prior to receipt of a COVID-19 vaccine is not recommended.
UMMS OB Leadership Recommendations
Women without mandatory contraindications should be offered vaccination according to their individual risk factors.
- For list of contraindications please refer to FDA EUA Fact Sheet for Healthcare Providers.
- Decision to vaccinate in pregnancy (especially early pregnancy) should be based on a risk/benefit analysis including consideration of deferral until vaccines with data in pregnancy are available.
- Timing of COVID-19 vaccination should be carefully coordinated with other vaccines given during prenatal care to avoid co-administration, in accordance with CDC/ACIP recommendations.
Pregnant and breastfeeding/lactating women who decline vaccination should be supported in their decision.
In conversations about vaccination please remember the importance of other prevention measures such as physical distancing, wearing a mask, and hand hygiene.
References